Skip to main content
. 2014 Jul 16;2014(7):CD009471. doi: 10.1002/14651858.CD009471.pub2

Doull 1995.

Methods Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial
Sponsor: Allen and Hanbury (UK) and the Wessex Medical Trust
Participants Setting: 5 health centres in the Southampton area
Eligible: 104
Randomly assigned: 52 (beclomethasone 200 μg); 52 (placebo)
Analysed: 44 (beclomethasone 200 μg); 40 (placebo)
Gender (male): 70.1%
Age, months, mean ± SE: beclomethasone 100.3 ± 1.4; placebo 99.4 ± 1.6
Inclusion criteria: children 7 to 9 years of age, with 5 or more wheezing episodes in the preceding year or an episode of wheezing lasting for 3 days or longer in the preceding year
Exclusion criteria: use of inhaled or oral corticosteroids; severe respiratory disease such as cystic fibrosis
Previous regular use of ICS: not allowed
Interventions Test group:
  • Beclomethasone, 400 μg/d


Control group: matching placebo
Treatment was delivered twice daily via Diskhaler. Treatment duration was 7 months, followed by a washout period of 4 months
Outcomes
  • Linear growth velocity (mm/wk)

  • Change in height over time (cm)

  • Adrenal function (overnight urinary cortisol).


Height was measured by a single observer in triplicate at each visit, using a Raven monitor
Notes Treatment compliance was measured by counting the used Diskhaler blisters. Compliance rate was 75.2% in the beclomethasone group and 75.9% in the placebo group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details provided
Allocation concealment (selection bias) Unclear risk No details provided
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Use of matching placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Use of matching placebo
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Withdrawal rate was 2/52 (3.8%) in the beclomethasone group and 8/52 (15.4%) in the placebo group
Selective reporting (reporting bias) Low risk Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified
Other bias Low risk Study appears to be free of other sources of bias